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PD-L1 IHC 22C3 pharmDx Overview

PD-L1 IHC 22C3 pharmDx is the ONE clinically proven assay at FIRST LINE and beyond

To aid in the identification of NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).

Key benefits of PD-L1 IHC 22C3 pharmDx

PD-L1 22C3 IHC pharmDx is the only companion diagnostic approved by the FDA as an aid in identifying NSCLC patients for treatment with KEYTRUDA.

Learn more about the key benefits

Incorporate PD-L1 testing early

Incorporate into your diagnostic lung panel to provide clinically relevant results linked to patient outcomes.

Read about early testing

PD-L1 webinar series: Comprehensive education for the entire pathology lab

The 2017 Educational Program lectures with prominent pathologists can be attended live or on-demand. The series has been developed in close cooperation with moderator Prof. Dr. Rector Magnificus Han J. M. van Krieken, Radboud University, Nijmegen, The Netherlands.

Access the program

Scoring Guidelines for KEYTRUDA

Validated scoring guidelines help identify patients more likely to respond to KEYTRUDA treatment.

Scoring guidelines

PD-L1 IHC 22C3 pharmDx
e-Learning Program

Get the training that may help you accurately evaluate and score PD-L1 expression in patients with NSCLC for KEYTRUDA by participating in the PD-L1 IHC 22C3 pharmDx Pathology Training Program.

Learn more and access the program >

22C3 Staining Atlas - an additional resource for you

Use the 22C3 Staining Atlas to increase your familiarity and confidence in scoring PD-L1 stains.

Learn more and access the staining atlas

Experience easy integration of PD-L1 testing in your IHC workflow

The first and only FDA-approved test to assess patients with NSCLC for KEYTRUDA.

  • Ready-to-Use reagents optimized for Autostainer Link 48
  • Cell line controls for enhanced confidence in results
  • Results can be available within one working day

Product: PD-L1 IHC 22C3 pharmDx

Platform: Autostainer Link 48

Code: SK006

1. PD-L1 IHC 22C3 pharmDx - Package Insert

2. Keytruda [package insert]. Kenilworth, NJ: Merck & Co., Inc.; 2016.

3. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. See the KEYTRUDA product label for expression cutoff values guiding therapy in specific clinical circumstances.

4. Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387(10027):1540-50.

5. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. NEJM 2016. DOI: 10.1056/NEJMoa1606774.

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Intended Use

For in vitro diagnostic use

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.